Just in Time labeling does not have to be stressful. A better understanding can make it less daunting.
Facing Fears of Just in Time Labeling
Just in Time labeling does not have to be stressful. A better understanding can make it less daunting.
You have poured over the plans again and again. There is no way around it. Your drug product is either limited or expensive. Perhaps it is utilized in pooled supply, short-dated, or there is limited stability data. In any of these scenarios, you will need the most efficient and flexible clinical packaging process possible. You will need Just in Time (JiT) labeling.
This realization could be cause for stress management techniques but it does not have to be stressful. With careful planning, a reliable process can be put in place to label and ship your product in a very short period of time.
Why use JiT labeling?
JiT labeling improves efficiency, decreases waste and reduces cost by labeling goods at the precise moment they are needed in the production process. It can replace or strengthen the traditional labeling process.
In a perfect world, traditional labeling works wonders. You develop a clinical supplies plan. You produce more than enough product and you ship it in large quantities to each site. Unfortunately, we do not live in a perfect world. There are many scenarios where traditional labeling is not feasible or economical.
How does JiT labeling work?
JiT labeling may mean one thing to a big pharma company, and quite another to a virtual company. It means still something else to a CMO versus a clinical site. The differences stem from the point in the process when the label or labels are added, and the method used.
Traditional labeling occurs early in the clinical supply chain, whereas JiT labeling usually occurs later in the process, to keep the supply available longer, thereby enhancing both flexibility and efficiency.
There are three primary JiT labeling scenarios:
JiT labeling at the point of distribution: In this scenario, your drug product can be packaged with a primary label and then stored, awaiting a request for distribution to clinical sites, warehouse or distribution depots. Getting part of the labeling process out of the way means that when a request for product comes, it is a relatively quick job to apply an ancillary label which further identifies the product, adding for example a patient ID number, material ID numbers and/or protocol numbers. This method is well-suited for smaller labeling projects.
JiT labeling for pooled supplies: In the case of pooled supplies, the label cannot be finalized until the moment of request. Requests may vary by dosing, country of shipment, language, regulatory requirements and so on. As such, the pooled supply is either unlabeled or partially labeled until it is needed, at which point it is processed specific to each protocol/study or compassionate use (a situation in which a clinical study is completed, but distribution is allowed to continue for patients who experienced significant benefits), and readied for distribution.
JiT labeling for retest/expiry dating: In situations where a product is already labeled it may be necessary to apply an ancillary label that has been dedicated for a particular drug study program. Expiry date and retest date labeling are the most common JiT labeling requests. Anyone who has explored this method knows that QP co-operation is imperative for this type of JiT labeling to be successful. Approval from QP and processes set up at the depots weigh heavily in this type of labeling form.
Does my product need JiT labeling?
JiT labeling is not for everyone or every study, but it is a great solution for many issues that can arise, including an expensive or scarce API, a short shelf life, or a sensitive API, such as one that requires cold storage and refrigerated transportation. Many drugs fall into one of these categories, especially as one in three drugs currently in development are biologics.
Let us suppose that, by some stroke of fortune, your product is economical, plentiful and stable. You still face the risk that study demands will change on short notice. You could mass produce, package, ship and store, only to learn that the study has changed and the product is no longer needed in Massachusetts but will now be needed in California. Or that your forecasted need for North Carolina was much too high and the actual demand is coming from San Francisco.
In most cases JiT is the most cost-effective and efficient way of making sure all of your studies receive the drugs they need, when they need it, without waste. There are only a few situations where JiT may not be feasible, such as extremely rapid enrollment situations, and complicated blind studies.
How do you design the JiT process?
In today’s world, trial design can be extraordinarily complex. We have multi-arm adaptive trials, multiple protocols for a single product, and we often share these studies across dozens of countries involving potentially hundreds of clinical sites and thousands of patients. It is important to ensure your product is right there, right when you need it. A good JiT system should be able to dispatch a shipment of product within 48-72 hours of receiving the order—sometimes much faster.
The planning for a good JiT process begins early. A label should be developed at the beginning as you are planning your clinical supplies needs. It is best to create a template label that works for most anticipated situations. Things to consider for your label include the dosing environment (clinical sites vs. at home usage settings), complexity of trials, number of trials, value of product, geographies/regulatory environment, shelf life, kit design, surface area, and use of electronic systems for managing supply.
It is important to choose a process that allows for maximum process elasticity in labeling. QP release requirements vary from country to country and protocol to protocol. A little research and a well-selected partner can help tailor the optimal scenario for your needs. Ideally, the final identifying label should be applied at the site level, allowing for maximum flexibility, since the product can be reassigned up until the moment it is dispensed.
As site labeling is often not feasible, labeling frequently takes place at your CMO site. If, for example, France needs 10 kits, a CMO labeling process might work like this: A supply request triggers the process, 10 kits are pulled from storage, a labeling room is set up, and the previously agreed upon JiT labeling procedure is set in motion. This may take four or more hours to train the team on the specific project, room setup, labels application, batch record prep and close-out, QA sign off, before releasing the shipment to the site.
What size CMO?
For companies that require quick turnaround times, the size of your CMO matters. A large CMO may not have the flexibility to respond immediately to a request. If a packaging room is made available for your product on short notice, it will likely be expensive. Smaller CMOs can often make a packaging suite available to accommodate JiT labeling runs at a moment’s notice. That suite will then remain available awaiting your request even if the trial lasts for weeks or months. When the order comes through, smaller CMO can typically dedicate staff to the project and complete it within hours. Such a process can substantially reduce shipment times and may come at a lower rate charged by large CMOs.
Communicating with your CMO about QP release at their depot is crucial. If a delay in your process arises, this is usually where it will be: the product is labeled and ready to ship, but the QP is tied up on other projects and unavailable to sign off. This causes the whole project to be needlessly delayed. Similarly, the QP in your own company should be available to check off the product immediately upon receipt.
JiT labeling optimizes the clinical packaging process and addresses challenges related to global competition, biotechnology products, and focus on cost efficiency and flexibility in your supply.
May Wattie Singh is Director of Business Development, Clinical Supplies at Xcelience, LLC. Prior to joining Xcelience, she worked for 15 years in the industry, developing her skills through clinical supplies management positions with Sharp, Catalent and McKesson Bio-Services. May has earned the reputation for her knowledge in the Clinical Supplies Management arena and is recognized as an industry-leading expert in clinical packaging and global distribution. She currently resides in Maryland, but travels regularly throughout the United States. She can be contacted at [email protected].